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Philips Respironics Amara Gel SE Mask - HSA Registration DE0014530

Access comprehensive regulatory information for Philips Respironics Amara Gel SE Mask in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0014530 and owned by Respironics, Inc.. The device was registered on December 23, 2013.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS B
DE0014530
Philips Respironics Amara Gel SE Mask
HSA Registration Number: DE0014530
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Product Description

The Amara SE Full Face Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators which have adequate alarms and safety systems for ventilation failure, and which are intended to administer CPAP or positive pressure ventilation for treatment of respiratory failure, respiratory insufficiency or obstructive sleep apnea. The mask is for multi-patient use in the hospital/institutional environment only. The mask is to be used on patients (>66 lbs/30kg) who are appropriate candidates for noninvasive ventilation

Device Classification
Device Class
CLASS B
Medical Speciality Area
General Hospital
HSA Product Code
HSAMDB00102
HS Code
90200000
Registration Information
Registration Number
DE0014530
Registration Date
December 23, 2013
Retention Due Date
December 22, 2025
Product Owner
Short Name
Respironics, Inc.
Address
1001 Murry Ridge Lane, Murrysville, PA 15668, UNITED STATES
Registrant
Address
622 LORONG 1 TOA PAYOH, SINGAPORE 319763
Importer
Address
25 LI HWAN TERRACE, GOLDEN HILL ESTATE, SINGAPORE 556953 3 MOUNT ELIZABETH, MOUNT ELIZABETH HOSPITAL, #12-13, SINGAPORE 228510 17 KAKI BUKIT PLACE, EUNOS TECHPARK, #---, SINGAPORE 416195 7030 ANG MO KIO AVENUE 5, NORTHSTAR @ AMK, #04-20, SINGAPORE 569880 622 LORONG 1 TOA PAYOH, #L3-NA, SINGAPORE 319763 2 JALAN RAJAH, GOLDEN WALL FLATTED FACTORY, #05-20, SINGAPORE 329134 246 MACPHERSON ROAD, BETIME BUILDING, #03-01, SINGAPORE 348578
Model Information
Model Name(s)
Silicone Pillow Forehead Pad RP Trueblue Hgr Clips RP-RS Amara Frame RP Amara Frame RP-P Amara Cushion RP-S Amara Cushion RP-M Amara Cushion RP-L Amara Cushion RP-RS Amara Headgear RP Amara Headgear RP-Amara Sizing Gauge P Amara Gel Mask SE w/RS Frame and RS Hgr Int S Amara Gel Mask SE w/RS Frame and RS Hgr Int S Amara Gel Mask SE w/Hgr Int M Amara Gel Mask SE w/Hgr Int L Amara Gel Mask SE w/Hgr Int M Amara Gel Mask SE w/RS Frame and RS Hgr Int L Amara Gel Mask SE w/RS Frame and Hgr Int
Model Identifier(s)
1040114 1071877 1090288 1090289 1090290 1090292 1090293 1090294 1090296 1090297 1090299 1090430 1090431 1090432 1090433 1090434 1090435 1090436